Workshop on Higher Education and Professional Responsibility in CBRN Applied Sciences and Technology across the Sub-Mediterranean Region 3-4 April 2012. Palazzo Zorzi, Venice Session 3. Inspiring Initiatives and Scientific Cooperation

1. Importance of ethics, bio-security
and good practices for better
scientific collaboration
Hechmi Louzir, Institut Pasteur de Tunis
13, Place Pasteur, 1002, Tunis-Belvédère, Tunisia
http://www.pasteur.tn

2. Introduction
• Interconnection and interdependence affect many
global challenges like health, food resources, energy,
• Scientific cooperation is essential to address and
reduce the burden of the global challenges.
• Collaboration between scientists contributes to build
capacity and help address the problems we face.
• Multidisciplinary is now essential for large projects.

3. Introduction (II)
• The world is facing changes that science continues to
explore the challenges.
• This creates a situation of public concerns on the
ethical aspects and the risk associated with this
research.
• The present and future generations of scientists are
facing the enormous challenge of developing socially
relevant research that could be translated into
practice.

4. www.pasteur.tn
Institut Pasteur
de Tunis
Over a century at the service
of Public Health
• Biomedical Analysis and Public Health Activities
• Manufacturing of therapeutic sera and vaccines
• Research & development
• Training

5. Research & development
Field of activities
 Infectious diseases +++ (national health priorities)
Leishmaniasis, hydatidosis, tuberculosis, viral
hepatitis, rabies, papillomavirus, enteroviruses, avian
virus, other veterinary microbial diseases, etc.
 Scorpion and snake envenoming
 Congenital immune deficiencies
 Genetic susceptibility to metabolic and infectious
diseases, cancer
 R&D biotechnology and bioprocesses

6. Research & development
Financial support
•National support through the eligibility of the groups
to be Research Laboratories (9) supported by the
Tunisian Ministry of Higher Education and Scientific
Research
•International financial supports from European
Commission-PCRD; World Health Organization/TDR;
National Institutes of Health; Walter Reed Army
Institute of Research; International Agency of Atomic
Energy; The Wellcome Trust; Agence Nationale de
Recherche; OTAN; The network of Pasteur Institutes-
RIIP; NEPAD; TWAS; notably).

7. International Partners of Institut Pasteur de Tunis
15 funding agencies
66 ongoing research projects
More than 75 partners institutions in 28 countries
CSE-Juin 2011

8. 140 Scientific publications of IPT 130
122
120
111
Publications international journals 102
100 94
87
Publications nationals
80
73
TOTAL 65
58
60
49
40 41
38
40 35 36
33
27 27
20
9 8 9 8
7 6 7
2
0
0
2003 2004 2005 2006 2007 2008 2009 2010 2011

9. Patents
 Chimeric polypeptide useful as a medicament comprises a selectin C-type lectin domain joined through a linker to an integrin von Willebrand
A domain having a metal ion-dependent adhesion site (FR2909672, 2008-06-13) FATHALLAH MOHAMED DAHMANI; JARBOUI MOHAMED ALI;
DELLAGI MOHAMED KOUSSAY
 METHOD FOR PREPARING RECOMBINANT MYCOBACTERIAL POLYPEPTIDES IN YEAST AND THEIR USE IN DIAGNOSIS OF MYCOBACTERIAL
RELATED DISEASES (WO2008010096, 2008-01-24 ). FATHALLAH MOHAMED DAHMANI (TN); BARBOUCHE MOHAMED RIDHA (TN); HO JOHN L (US);
BENABDESSELEM CHAOUKI (TN); DELLAGI KOUSSAY (TN); LARGUECHE BEYA (TN)
 RECOMBINANT PICHIA PASTORIS STRAINS AND PROCESS FOR THE PRODUCTION OF RECOMBINANT HUMAN INTERFERON ALPHA
(WO2007099462, 2007-09-07) FATHALLAH MOHAMED DAHMANI (TN); KALLEL HELA (TN); DELLAGI KOUSSAY (TN); REBHI IMEN (TN); AYED ATEF
(TN)
 MAUROCALCINE, ANALOGUES THEREOF AND THEIR THERAPEUTICAL USES (DE60126067D, 2007-03-08) KHARRAT RIAD (TN); MABROUK KAMEL
(FR); EL-AYEB MOHAMMED (TN); ROCHAT HERVE (FR); SABATIER JEAN-MARC (FR)
 GENE ASSOCIATED WITH LEISHMANIA PARASITE VIRULENCE (YU99603, 2006-05-25) BEN ACHOUR YOSSER (TN); CHENIK MEHDI (TN); LOUZIR
HECHMI (TN); DELLAGI KOUSSAY (TN)
 POLYPEPTIDES OF LEISHMANIA MAJOR AND POLYNUCLEOTIDES ENCODING SAME AND VACCINAL, THERAPEUTICAL AND DIAGNOSTIC
APPLICATIONS THEREOF (WO2006108720, 2006-10-19) CHENIK MEHDI (TN); LAKHAL SAMI (TN); LOUZIR HECHMI (TN); DELLAGI KOUSSAY (TN)
 COMPOSITION COMPRISING THE N-TERMINAL REGION OF LEISHMANIA HISTONE H2B, USE THEREOF FOR INDUCING AN IMMUNE RESPONSE
(WO2006097642, 2006-09-21) CHENIK MEHDI (TN); LOUZIR HECHMI (TN); DELLAGI KOUSSAY (TN)
 LEISHMANIA ANTIGENS SUITABLE FOR A DIAGNOSTIC KIT OF LEISHMANIA (WO2006079565, 2006-08-03) DELLAGI KOUSSAY (TN); KAMOUN-
ESSGHAIER SAYDA (TN); GUIZANI IKRAM (TN)
 USE OF ZKW PEPTIDE FOR PREPARING AN INHIBITOR DRUG AGAINST PLATELET AGGREGATION (WO2005014021, 2005-02-17) MARRAKCHI
NAZIHA (TN); MABROUK KAMEL (FR); SABATIER JEAN-MARC (FR); EL AYEB MOHAMED (TN); ROCHAT HERVE (FR)
 Amino-butyrate derivatives of venoms (GB2335923, 1999-10-06) SABATIER JEAN-MARC (FR); EL-AYEB MODHAMMED (TN); VAN RIETSCHOTEN
JURPHAAS (FR); ROCHAT HERVE (FR)
 LEBETIN PEPTIDES AS PLATELET AGGREGATION INHIBITORS (WO9829436, 1998-07-09) ROCHAT HERVE (FR); MABROUK KAMEL (FR); EL-AYEB
MOHAMMED (TN)
 VACCINE COMPOSITION COMPRISING RECOMBINANT BCG EXPRESSING GP63 FUSION PROTEIN (WO9610081, 1996-04-04) GICQUEL BRIGITTE
(FR); ABDELHAK SONIA (FR); DELLAGI KOUSSAY (TN); LOUZIR HECHMI (TN)

10. Funding agencies (alphabetic order) Nature of the grant
ANR (Paris, France) R&D
BIO-RAD (Paris, France) Patent strengthening
European Commission (Brussels, Belgium) R&D
Fondation Mérieux (Lyon, France) Euro-Mediterranean Public Health
Information System
Fort Dodge Animal Health Vaccine development and validation
International Atomic Energy Agency
(Vienna, Austria) R&D capacity building and training
Institut Pasteur International Network
(Paris, France) R&D and Public Health Activities (control)
Joint WHO/EMRO-COMSTECH
(Islamabad, Pakistan) R&D
National Institutes of Health (Maryland, USA) R&D, clinical research
North Atlantic Treaty Organization
(Brussel, Belgium) R&D
The New Partnership for Africa’s Development
(Johannesburg, South Africa) R&D
Walter Reed Army Institute Of Research
(Washington, USA) Clinical trials (phase II and phase III)
Welcome Trust (London, UK) R&D, training
WHO/EMRO (Cairo, Egypt) R&D for control
World Health Organization TDR
(Geneva, Switzerland) R&D, capacity building, training

11. The Institut Pasteur
International Network

12. Institut Pasteur
de Tunis
ANDI Centre of Excellence for Bio-molecules
Discovery
African Network for Drugs and Diagnostics Innovation (ANDI), United Nations Economic Commission for Africa
(UNECA), Menelik II Avenue, PO Box 3001, Addis Ababa, Ethiopia. Tel: +251 11 544 362; E-mail: info@andi-africa.org

13. Norms &Regulations
• Ethical aspects (based on the different recommendation issued
by the international community)
• The IPT has an Institutional Review Board (IRB) established since
1992, the first in Tunisia (before the National Committee of
Medical Ethic).
• The IRB meets to review proposals and relevant files and consent
forms and, if needed, to provide corrective measures.
• Clearance is only provided when the revised application meets
ethics.
• The transfer of biological material (between the IPT and other
national or international research Centers) is governed specific
procedure (MTA)

14. Norms &Regulations (II)
• Compliance with good practice (clinical, laboratory, production):
• Good Manufacturing Practice (GMP): IPT remains the only
producer of vaccines and sera for human use in Tunisia. Our
production is conducted according to current GMP and is
focused on BCG and anti-sera (anti-rabies, anti-scorpion and anti-
viper).
• Now, efforts were developed to introduce Good Clinical Practice
(GCP) in clinical trials.
• Presently, the IPT is in the phase of introducing Good Laboratory
Practice (GLP). Quality assurance is implemented at different
levels with a specific committee (since 2008).
• Aspects related to bio-safety and protocols for genetically
modified organisms (GMO): role of our Hygiene and Security
Committee.

15. Actions planned or ongoing in IPT
• A monitoring committee of deontology (Comité de Veille
Déontologique), created in 2012: A code of scientific
deontology will be established, it will clearly state the rules of
good conduct in research teams and investigation and seeks to
respect people and their scientific work (conflict between
researchers, students, fraud, plagiarism, etc.).
• A committee for animal welfare: it will establish the rules and
conditions for research using vertebrates animals.
All these rules, standards and procedures are required
for good scientific collaboration. In some institutions
gaps exists, they constitute real barriers for success in
grant applications and scientific dissemination

16. Management of Intellectual Property
Rights
• Research is unethical if the results are not translated into practice for
the benefit of patients and society.
• It is the duty of the research team to make the necessary efforts to
decision makers for translating the research results into practice.
• At IPT, we have a small team in charge of all aspects related to IP,
Technology Transfer, Valorization/Communication and promotion of
Research projects:
- Establish rules and procedures for declarations of invention,
patenting.
- Valorization of patents and other know-how to promote industrial
applications, including public-private partnership.
This is the best way for that research can
lead to products that serve those in need.

17. Conclusion
• For a good international collaboration a
particular attention should be put
regarding legal, ethical and procedural
aspects, including IP.
• It is the role of Scientists, Policy makers,
Civil society, and Managers of research
organizations.